Job Description

Job Title: Sr Manufacturing Associate, Drug Product

Location: Lexington, MA

How will you make an impact?

Performing critical downstream activities in preparation for fill finish of Drug Product.

What will you do?

2022 Performing basic to complex activities on the fill finish line for production of Drug Product.
2022 Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
2022 Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
2022 Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
2022 Monitor assigned processes using automated production systems and controls with limited supervision.
2022 Equipment preparation activities including, parts cleaning, autoclaving, and room clearance.
2022 Demonstrates ability to troubleshoot basic mechanical operations.
2022 Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.
2022 Daily Aseptic processing within a controlled isolator environment and within a BSC.
2022 Performs batch record review, procedure revisions, and work order generation.
2022 Fulfills role of lead trainer on numerous operations and is an area SME.
2022 Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.
2022 Work in accordance with site and company EHS programs.
2022 Work in accordance with regulations, detailed protocols, Batch Record2019s, SOP2019s and Work Instructions.
2022 Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.

Education

2022 Prefer a Bachelor's in Chemistry, Biology or related field. Or a combination of education and experience will be considered.

Knowledge, Skills, Abilities

2022 Ability to aseptically gown and/or sterile gown as needed.
2022 Effectively utilizes Microsoft office applications.
2022 Must be able to work in a fast-paced environment.
2022 A strong attention to detail through a 8-hour shift.
2022 Work towards solutions to given problems and operate under cGMP requirements.
2022 Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, MST, Quality Control and Quality Assurance.
2022 Qualify to work in aseptic environments to complete required production activities.
2022 Maintain facility and room inspection readiness.
2022 Ability to lift at least 50lbs.